We are an international fast growing healthcare company and as a result of our rapid growth we are looking for:
Pharmacovigilance Officer (m/f)
PrimeVigilance is continuing to expand and is looking for a Pharmacovigilance Officer to join our dynamic and rapidly expanding organization.
Based in our office in Zagreb, the Pharmacovigilance Officer will be primarily responsible to process Quality Control (QC) of Individual Case Safety Reports (ICSRs) and to provide support to PV Project Manager and project team in other
activities undertaken on behalf of the client and the company.
- Performing Individual Case Safety Report (ICSR) quality control (QC)
- Closing processed ICSRs
- Reviewing the content of the request for submission e-mail prepared by PV Associate (for expeditable ICSRs and case exchange)
- Performing ICSR reconciliation with business partners, if required
- Tracking ICSRs
- Translating documents into English, if applicable
- Writing or contribute to aggregate reports as required. This may include acting as the project co-ordinator, collating the needed information, incorporate reviewers’ comments and finalising the document.
- Writing or contributing to signal detection activities as required. This may include collating the needed information and preparing the draft signal detection reports
- Supporting project manager, as necessary
- Performing initial ICSR triage and case assessment
- Line managing the team of PV Associates and PV Assistants, depending on the project team structure
- Assisting with PV processes, supporting preparation of Standard Operating Procedures, product safety reviews and literature reviews as required
- Training and mentoring of other more junior employees in the field of expertise, performing on-going evaluation, periodic appraisals, mentoring and training the employees reporting to them (if applicable)
Qualifications and Skills:
- Educated to degree level or above in life sciences or a related field
- Min 2 years’ working experience in Pharmacovigilance (CRO or pharma company)
- Fluent knowledge of English (written and oral) plus preferably another European language (Norwegian, Finnish, Swedish, Flemish, Slovakian, Slovenian, Czechoslovakian and Polish)
- Advanced knowledge of MS Office (Word, PowerPoint, Excel)
- Excellent interpersonal, verbal and written communication skills
- Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives
- Ability to work effectively in an international matrix team and value the importance of teamwork
- Competitive salary
- Work within a successful, highly – qualified and dynamic team
- Professional training and career development in a fast growing healthcare company
If you would like to be considered for this opportunity, please send your application via
application link enclosing your English CV and Cover Letter.
Due to high a volume of applications only short-listed candidates will be contacted.
Deadline for applications: 23.03.2018.